In a guest column for Life Science Connect, Nelson Mullins partner John Claud examines the U.S. Food and Drug Administration’s (FDA) newly launched one-day facility inspection pilot and what it could mean for the future of regulatory oversight. Claud delves into the potential benefits of the program, while also addressing questions surrounding implementation, resource constraints, and long-term viability.  

If the one-day inspection program continues under new leadership, the more practical question becomes what an investigator can realistically accomplish in a single day. In many traditional inspections, the first day is largely devoted to safety orientation, facility familiarization, and the investigator’s preliminary review of operations. Compressing an entire visit into that timeframe assumes investigators have already completed substantial record review remotely in advance, meaning a few hours on-site would depend on several days of off-site preparation.

Read the full article here.